FDA's Warning About Teething Products Gets Quick Response

The FDA released an advisory statement warning parents to avoid homeopathic teething tablets and gels, including those sold by Hyland’s or CVS. The FDA is investigating reports of possibly related seizures and other adverse events in children and infants who have also used the teething products.

Homeopathic remedies have grown in popularity and are available at most drugstores, although they aren't regulated for quality, safety or effectiveness by the FDA. Although it does not directly issue recalls on the consumer products, leaving that up to the manufacturer, the FDA recommends that consumers stop using these homeopathic teething products and dispose of any they have on hand.

In response to the FDA’s warning, Hyland’s has voluntarily decided to discontinue distributing its teething products in the United States, while CVS has immediately pulled all of its own brand of homeopathic teething products from its shelves, as well as Hyland’s and Baby Orajel Naturals.

“Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels,” the FDA said in its statement.¹

In 2010, the FDA issued a safety alert about homeopathic teething tablets in which it found “inconsistent” amounts of belladonna and reports of serious side effects consistent with belladonna toxicity from several consumers.²

Hyland’s Homeopathic has issued a response to the most recent FDA advisory on its website: “There is no current recall of Hyland's Baby Teething Tablets. ... Hyland’s Baby Teething Tablets have safely treated the pain associated with teething for more than 85 years. There is NO scientific link between homeopathically-prepared belladonna, or Hyland’s Baby Teething Tablets, and seizures."³

Since the new warning was released on September 30, 2016, Hyland’s issued a letter to its consumers explaining why they are discontinuing distribution of their teething products in the United States, in which they maintain that the products are safe to use.⁴

The American Academy of Pediatrics recommends managing teething with one of the following cold items because the cold acts as an anesthetic for gums:

• Pacifiers
• Spoons
• Clean, wet washcloths
• Frozen bagels or bananas
• Refrigerated teething rings

The FDA is currently investigating this issue, including testing product samples. The agency will continue to communicate with the public as more information is available.²

References

1. FDA Press Announcement: FDA warns against the use of homeopathic teething tablets and gels. FDA website. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm523468.htm.

2. FDA Safety Alert: Hyland’s Teething Tablets may pose a risk to children. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm230761.htm

3. Hyland’s Media — Press Release. Hyland’s reponse to FDA advisory regarding homeopathic teething tablets and gels. Hyland’s website. hylands.com/media/press-release/hylands-response-fda-advisory-regarding-homeopathic-teething-tablets-and-gels.

4. A letter from Hyland’s. October 11, 2016. Hyland’s website. hylands.com/hylands-discontinues-teething-tablets-and-gels.